Study on Five Fraction Radiation Therapy for Advanced Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06369246

Provider View

This clinical trial is testing the safety and effectiveness of a new radiation therapy approach, called stereotactic body radiation therapy (SBRT), for treating advanced or high-risk prostate cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new radiation treatment method, called stereotactic body radiation therapy (SBRT), for patients with advanced or high-risk prostate cancer. Researchers aim to determine if this treatment is safe and effective in managing the disease.

Description

The study has several goals:

  • Primary Goals:

    • To find out how many patients experience significant gastrointestinal (GI) side effects three months after receiving the new radiation treatment.
    • To assess changes in patients' quality of life, including urinary, bowel, and sexual function, before and after treatment, using specific questionnaires.

  • Secondary Goals:

    • To estimate how long patients remain free from cancer spread within 24 months of joining the study.
    • To evaluate the rate of early and late side effects related to the treatment.
    • To ensure the treatment is delivered according to the study's guidelines, using advanced technology to improve accuracy and efficiency.
    • To explore the impact of the treatment on white blood cell counts, comparing them to historical data.
    • To assess changes in quality of life over time, at various intervals after treatment.

  • Exploratory Goal:

    • To investigate how the treatment affects the gut microbiome by collecting samples before and after treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer within the last year, confirmed by lab tests.
  • Cancer stage between cT1c and T3a, with specific Gleason scores.
  • If Gleason Grade 2, must meet certain risk criteria.
  • No cancer spread to lymph nodes on standard imaging.
  • Aged 18 or older.
  • Previous hormone therapy for prostate cancer is allowed if started within 185 days before joining the study.
  • General health status allowing participation (ECOG score 0-2).

Exclusion Criteria

  • Have active autoimmune diseases like scleroderma or lupus that may interfere with safe radiation treatment.
  • Have had previous prostate surgery or certain other treatments for prostate cancer.
  • Have had prior radiation in the same area that would overlap with the study treatment.
  • Have cancer that has spread to distant parts of the body and cannot be treated effectively.

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